Gomori's Trichrome Stain
FDA 510(k) K842930 · E K Ind., Inc.
510(k) numberK842930
Submission
- Device name
- Gomori's Trichrome Stain
- Applicant
- E K Ind., Inc.
Mchenry, IL, US - Received
- July 25, 1984
- Decision date
- September 11, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LED – Stains, Chemical Solution
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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|---|---|---|---|
| K051409 | SlivasureLED · Traditional | Scandinavian Formulas, Inc. | 08/08/2005SE |
| K023046 | SST Saliva Supporting TabletsLED · Traditional | Sinclair Pharmaceuticals, Ltd. | 12/02/2002SE |
| K860795 | Spottest Calcofluor White ReagentLED · Traditional | Difco Laboratories, Inc. | 03/12/1986SE |
| K860321 | LysocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860320 | GranulocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860319 | MegacolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860317 | NeutrocolorLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K860316 | PanoptikonLED · Traditional | Cytocolor, Inc. | 02/20/1986SE |
| K854176 | Polychrome IV StainLED · Traditional | Devetec, Inc. | 10/31/1985SE |
| K851481 | Spottest Iodine Solution Dobell & O'ConnorLED · Traditional | Difco Laboratories, Inc. | 04/29/1985SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K842931 | Drabkin ReagentKAG · Traditional | 09/21/1984SE |
| K842938 | Acetic Acid 1% V/VGGK · Traditional | 09/14/1984SE |
| K842937 | Acetic Acid 2% V/VGGK · Traditional | 09/12/1984SE |
| K842936 | Acetic Acid, 3% V/VGGK · Traditional | 09/12/1984SE |
| K842935 | Acetic Acid, 5% V/VGGK · Traditional | 09/12/1984SE |
| K842934 | Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional | 09/12/1984SE |
| K842933 | Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional | 09/11/1984SE |
| K842928 | Jenner Blood StainKJX · Traditional | 09/11/1984SE |
| K842927 | Light Green SF 1%HYS · Traditional | 09/11/1984SE |
| K842926 | Methylene Blue Stain, LoefflerKFC · Traditional | 09/11/1984SE |
Questions and answers
When was Gomori's Trichrome Stain cleared by the FDA?
Gomori's Trichrome Stain (K842930) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 48 days after the submission was received.
What is the product code of K842930?
The FDA product code is LED – Stains, Chemical Solution, a Class I (low risk) device regulated under 21 CFR 864.1850.